| CTRI Number |
CTRI/2021/08/035590 [Registered on: 11/08/2021] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of cold chest pack and facial steam with eucalyptus oil on pulmonary function test in tuberculosis patients |
|
Scientific Title of Study
|
Efficacy of cold chest pack and facial steam with eucalyptus oil on pulmonary function test in tuberculosis patients-A Randomized Control Trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrAdil |
| Designation |
Post Graduate Studen |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH 58 Bypass road Meerut
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH 58 Bypass road Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9058313472 |
| Fax |
|
| Email |
adilmalik78610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhiren Ajit Nair |
| Designation |
Assistant Professor and Post Graduate (PG) coordinato |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH 58 Bypass road Meerut
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH 58 Bypass road Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M Shankaregowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH 58 Bypass road Meerut
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH 58 Bypass road Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Subhartipuram, NH-58, Delhi Haridwar Bypass Road, Uttar Pradesh 250005 |
| Netaji Subhash Chandra Bose Subharti Medical College, Swami Vivekanand Subharti University, Subhartipuram, NH-58, Delhi Haridwar Bypass Road, Uttar Pradesh 250005 |
|
|
Primary Sponsor
|
| Name |
DrAdil |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences, Swami Vivekanand Subharti University,
Subhartipuram, NH-58, Delhi Haridwar Bypass Road, Uttar Pradesh
250005
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAdil |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Department of Post Graduate Studies Swami Vivekanand
Subharti University,
Subhartipuram, N.H.
58, Delhi-Haridwar,
By-pass road, Meerut
(U.P.), India- 250005
Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH |
9058313472
adilmalik78610@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMCUECM2021273155 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Allopathic Medicine |
On Allopathic Medicine Only |
| Intervention |
Cold Chest Pack and Facial Steam with Eucalyptus oil |
COLD CHEST PACK:
Cold chest pack is performed among the study participants in the sessions with a total duration of 30 mints, Patients are made to be in supine position/sitting position during intervention. The cold chest pack ,comprised cotton cloth which is approximately 2.5m long and .5m wide , should be loosely rolled up, dipped in to water at 58ºF -62ºF, and wrung out without unrolling .The moist bandage precisely the same manner to make it fit snugly at every point so as exclude the air. It will be applied over the chest covering both front and back. The cold chest pack was removed after 30 min.
FACIAL STEAM WITH EUCALYPTUS OIL:
Keep the pot on the table in front of the patients and Added 250 ml of water in a pot .heat the water until it is quite boiling ,just steamy.then added 3-4 droup of eucalyptus oil after that when steam genrate then tell patients forwords your head in front of the steam pot and closed your eye then inhalation your nose and exhalation of mouth.this procedure given for 2- 3 min.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Tuberculosis
Lungs involvement Tuberculosis
Subjects who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Open wound or scar on chest or back
Recent surgery
Psychiatric &neurologic disorder
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test (PFT) |
Basline, Post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| respiratory rate |
Baseline, Post intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized control Trial study to find the efficacy of cold chest pack and facial steam with eucalyptus oil on pulmonary function test on tuberculosis patients with sample size of 100 subjects. the outcome of study is pulmonary function test, respiratory rate.,with followup of 15 days which is done in Maharishi Aurobindo College and Hospital of Naturopathy and Yogic Sciences. |